Dual-functIon Semi-rigid thoraCoscOpy Versus semi-rigid thoracoscopy for the diagnosis of plEuRal diseases: protocol for a multicentre, open-label, randomised controlled trial in China (DISCOVER-I)

Our plain-English summary of Dual-functIon Semi-rigid thoraCoscOpy Versus semi-rigid thoracoscopy for the diagnosis of plEuRal diseases: protocol for a multicentre, open-label, randomised controlled trial in China (DISCOVER-I), by M. Deng, X. Liu, W. Chen, et al (Respiratory Research, 2026).

The study

• Authors: M. Deng, X. Liu, W. Chen, S. Wei, Z. Zheng, L. Liao, Q. Zhang, J. Li, R. Tong, J.M. Porcel, T. Wang, G. Hou
• Journal: Respiratory Research
• Published: 2026;27(1)
• Cited by: 1 article, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

BACKGROUND: Exudative pleural effusion often presents diagnostic challenges, with up to 25% of cases remaining undiagnosed after thoracentesis or closed pleural biopsy. Semi-rigid thoracoscopy is a widely used minimally invasive diagnostic method. However, its diagnostic yield is limited by small and superficial biopsy samples due to the lack of mechanical power, particularly in cases of thickened pleura or suspected mesothelioma. We had designed and developed a dual-function semi-rigid thoracoscope and semi-rigid forceps to improve sampling quality and depth. However, their diagnostic performance and safety, particularly compared with that of conventional semi-rigid thoracoscopy is still unclear. METHODS: This randomised controlled trial will enrol a total of 522 adults with exudative pleural effusions of unclear aetiology that remain undiagnosed after the initial investigations from 10 sites in China. Participants will be randomised (1:1:1) to undergo thoracoscopy using either a conventional semi-rigid thoracoscope (with flexible forceps) or a novel dual-function semi-rigid thoracoscope (with either semi-rigid forceps alone or a combination of flexible and rigid forceps). The primary outcome is diagnostic yield. Secondary outcomes include the biopsy success rate, incidence of procedure-related complications, biopsy specimen size and depth, histological interpretability, and adequacy of tissue for molecular marker analysis. DISCUSSION: We hypothesize that the dual-function semi-rigid thoracoscopy with semi-rigid forceps will achieve higher diagnostic yield than conventional semi-rigid thoracoscopy due to the larger and deeper sampling. If this hypothesis is validated, dual-function semi-rigid thoracoscopy could be a novel option for performing pleural biopsy for patients with unknown exudative pleural effusion. TRIAL REGISTRATION: This study has been registered at www.clinicaltrials.gov (ID: NCT06744725; Registration Date: 2024-12-19).

In plain English

This article is a protocol. It describes a planned trial and reports no results from the planned trial. The authors planned a multicentre, open-label randomised controlled trial in China, called DISCOVER-I. It was to enrol 522 adults with exudative pleural effusion (fluid around the lung) whose cause remained unclear after less invasive tests, at ten sites. Participants were to be assigned in equal numbers to one of three groups. One group would have conventional semi-rigid thoracoscopy with flexible forceps. The other two would have a new dual-function semi-rigid thoracoscope, used either with semi-rigid forceps alone or with flexible and semi-rigid forceps together. The authors hypothesized that the new thoracoscope with semi-rigid forceps would achieve a higher diagnostic yield than conventional semi-rigid thoracoscopy. The authors listed several limitations. The open-label design may introduce performance bias. Results at centres newly adopting the procedure may differ. The study focuses on diagnostic accuracy and short-term safety. Allowing crossover between groups complicates intention-to-treat comparisons. The article does not discuss asbestos.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Protocol for a multicentre, open-label randomised controlled trial (no results from the planned trial reported)
• Who was studied: Planned enrolment of 522 adults aged 18 or older with exudative pleural effusion of unclear cause after less invasive diagnostic procedures, at ten anticipated sites in China
• Exposure: Not an asbestos exposure study. The trial compares diagnostic instruments: conventional semi-rigid thoracoscopy with flexible forceps versus a new dual-function semi-rigid thoracoscope used with semi-rigid forceps alone or with flexible plus semi-rigid forceps, with participants randomised 1:1:1
• The authors' conclusion: The authors hypothesized that dual-function semi-rigid thoracoscopy with semi-rigid forceps would achieve a higher diagnostic yield than conventional semi-rigid thoracoscopy because of larger and deeper sampling
• Limitations the authors state:
  • The open-label design means operators cannot be blinded, which may introduce performance bias
  • Because of the learning curve, results from centres newly adopting the procedure may differ until proficiency is achieved
  • The study concentrates on diagnostic accuracy and short-term safety and does not monitor long-term outcomes
  • Allowing crossover to the dual-function device when adhesions prevent semi-rigid sampling complicates intention-to-treat comparisons

Topics

The National Library of Medicine indexes this study under subjects our site covers: Pleural plaques and thickening.

Medical terms in this study, explained in our Lexicon: Thoracoscopy, Pleural Effusion, Thoracentesis, Pleural Biopsy, Biopsy, Pleura, Mesothelioma.

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